Crane Safety Aspirin, Thompson Aspirin

Description

No description information is available for the drug.

Uses and Indications

This drug is indicated for the temporary relief of various types of pain and discomfort, including headache, muscle pain, toothache, menstrual pain, and minor pain associated with arthritis. Additionally, it is effective in alleviating pain and fever associated with colds.

There are no teratogenic or nonteratogenic effects associated with this drug.

Dosage and Administration

Patients should take the medication with a full glass of water to ensure proper absorption.

For adults and children aged 12 years and older, the recommended dosage is either 1 or 2 tablets every 4 hours, or 3 tablets every 6 hours. The total daily dosage must not exceed 12 tablets within a 24-hour period.

For children under 12 years of age, it is advised to consult a healthcare professional for appropriate dosing recommendations.

Contraindications

Use is contraindicated in individuals with a known allergy to aspirin or any other pain reliever or fever reducer. Due to the potential for severe allergic reactions, administration in these patients is not recommended.

Warnings and Precautions

Patients should be advised of the following warnings and precautions associated with the use of this product.

Reye's Syndrome Children and teenagers who are experiencing or recovering from chickenpox or flu-like symptoms should not use this product. If any changes in behavior accompanied by nausea and vomiting occur during use, it is imperative to consult a healthcare professional, as these symptoms may indicate the onset of Reye's syndrome, a rare but serious condition.

Allergy Alert Aspirin has the potential to cause severe allergic reactions. Healthcare professionals should be vigilant for signs of an allergic response, which may include hives, facial swelling, asthma (wheezing), or shock. Immediate medical attention is warranted if these symptoms arise.

Stomach Bleeding Warning This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may increase the risk of severe stomach bleeding. The likelihood of this adverse effect is heightened in patients who meet any of the following criteria:

• Are aged 60 years or older

• Have a history of stomach ulcers or bleeding disorders

• Are concurrently taking anticoagulants or steroid medications

• Are using other NSAIDs, whether prescription or over-the-counter (e.g., aspirin, ibuprofen, naproxen)

• Consume three or more alcoholic beverages daily while using this product

• Exceed the recommended dosage or duration of use

Monitoring Parameters Patients should be closely monitored for signs of stomach bleeding, which may include feeling faint, vomiting blood, passing bloody or black stools, or experiencing persistent stomach pain. Additionally, if pain worsens or lasts longer than 10 days, or if fever persists beyond three days, medical advice should be sought. Patients should also be advised to report any occurrence of tinnitus or hearing loss, redness, or swelling in the affected area, as well as any new symptoms that may develop.

Emergency Medical Help In the event of an overdose, it is critical to seek immediate medical assistance or contact a Poison Control Center without delay.

Side Effects

Patients using this product should be aware of several serious adverse reactions associated with its use. Notably, Reye's syndrome is a rare but serious illness that can occur in children and teenagers who have or are recovering from chickenpox or flu-like symptoms. If patients experience changes in behavior accompanied by nausea and vomiting while using this product, they should consult a healthcare professional immediately, as these may be early signs of Reye's syndrome.

Additionally, there is a significant risk of severe allergic reactions to aspirin, which may manifest as hives, facial swelling, asthma (wheezing), or shock. Patients should be vigilant for these symptoms and seek medical attention if they occur.

The product contains a nonsteroidal anti-inflammatory drug (NSAID), which carries a warning for the potential of severe stomach bleeding. The risk of this adverse reaction is heightened in patients who are 60 years of age or older, have a history of stomach ulcers or bleeding problems, are taking anticoagulants or steroid medications, are using other NSAIDs (including aspirin, ibuprofen, or naproxen), consume three or more alcoholic drinks daily, or exceed the recommended dosage or duration of use.

Patients are advised to discontinue use and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing persistent stomach pain that worsens or lasts longer than 10 days. Other concerning symptoms include a fever that worsens or lasts more than three days, ringing in the ears or loss of hearing, redness or swelling in the painful area, or the emergence of any new symptoms.

Before using this product, patients should seek medical advice if they have a history of stomach problems such as heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. It is also important to consult a healthcare professional if they are taking diuretics or prescription medications for gout, diabetes, or arthritis.

Drug Interactions

There are currently no documented drug interactions associated with this medication. Additionally, there is no information available regarding interactions with laboratory tests. As such, no specific recommendations for dosage adjustments or monitoring are warranted at this time.

Packaging & NDC

Below are the non-prescription pack sizes of Crane Safety Aspirin, Thompson Aspirin (aspirin). Columns show Packaging, Formulation Type, and Active Ingredient Strength.

Pediatric Use

Pediatric patients, particularly those under 12 years of age, should consult a doctor before using this product. It is contraindicated in children and teenagers who have or are recovering from chickenpox or flu-like symptoms due to the risk of Reye's syndrome, a rare but serious illness. If any changes in behavior accompanied by nausea and vomiting occur while using this product, a healthcare professional should be consulted, as these may be early signs of Reye's syndrome.

For adolescents aged 12 years and older, the recommended dosage is 1 or 2 tablets every 4 hours or 3 tablets every 6 hours, with a maximum of 12 tablets in a 24-hour period.

Geriatric Use

Elderly patients, particularly those aged 60 and older, are at an increased risk for severe stomach bleeding. It is essential for healthcare providers to exercise caution when prescribing medications that may exacerbate this risk in this population.

Before initiating treatment, healthcare providers should inquire about the patient's history of stomach problems, including but not limited to heartburn, high blood pressure, heart disease, liver cirrhosis, or kidney disease. Such conditions may further elevate the risk of gastrointestinal complications.

Close monitoring and appropriate dose adjustments may be necessary for geriatric patients to ensure safety and efficacy while minimizing the potential for adverse effects.

Pregnancy

Pregnant patients and those who are breastfeeding should consult a healthcare professional before using this medication. It is particularly important to avoid the use of aspirin after 20 weeks of gestation unless specifically directed by a physician, as it may pose risks to the developing fetus and lead to complications during delivery. Healthcare providers should carefully evaluate the potential benefits and risks when considering the use of this medication in pregnant patients.

Lactation

Lactating mothers are advised to consult a health professional before using this medication. It is particularly important to avoid the use of aspirin at 20 weeks of pregnancy or later unless specifically directed by a physician, as it may pose risks to the unborn child or lead to complications during delivery. There is no specific data available regarding the excretion of this medication in breast milk or its effects on breastfed infants. Therefore, caution is recommended when considering the use of this medication during lactation.

Renal Impairment

Patients with renal impairment have not been specifically addressed in the available prescribing information. There are no dosage adjustments, special monitoring requirements, or safety considerations outlined for individuals with reduced kidney function. Healthcare professionals should exercise caution and consider the lack of data when prescribing to this patient population.

Hepatic Impairment

Patients with hepatic impairment have not been specifically studied in relation to the use of this medication. Consequently, there are no established dosage adjustments, special monitoring requirements, or precautions outlined for individuals with compromised liver function. It is recommended that healthcare providers exercise caution when prescribing this medication to patients with hepatic impairment, given the lack of data on its safety and efficacy in this population. Regular monitoring of liver function may be prudent in these cases, although specific parameters are not defined in the available information.

Overdosage

In the absence of specific overdosage information, it is essential for healthcare professionals to remain vigilant and prepared for potential scenarios involving overdose.

Healthcare providers should be aware that the clinical presentation of an overdose may vary significantly depending on the substance involved and the individual patient’s characteristics. Symptoms may include, but are not limited to, altered mental status, cardiovascular instability, respiratory distress, and gastrointestinal disturbances.

In the event of suspected overdosage, immediate medical evaluation is recommended. Healthcare professionals should assess the patient's vital signs and conduct a thorough clinical examination. Supportive care should be initiated as necessary, which may include airway management, intravenous fluids, and monitoring of vital parameters.

If specific antidotes or treatments are available for the substance involved, they should be administered according to established protocols. Consultation with a poison control center or toxicology expert may also be warranted to guide management decisions.

It is crucial to document all findings and interventions in the patient's medical record to ensure continuity of care and facilitate further treatment if required.

Nonclinical Toxicology

It is especially important to avoid the use of aspirin at 20 weeks of gestation or later unless specifically directed by a healthcare professional, as it may lead to complications for the unborn child or during delivery. No relevant information regarding non-teratogenic effects has been provided. Additionally, there is no available data concerning nonclinical toxicology or animal pharmacology and toxicology.

Postmarketing Experience

No specific postmarketing experience details are available in the extracted data. As such, there are no additional adverse events or rare case reports to summarize at this time.

Patient Counseling

Healthcare providers should advise patients to keep the medication out of reach of children to prevent accidental ingestion. In the event of an overdose, patients should be instructed to seek medical help or contact a Poison Control Center immediately.

Patients must be informed not to use the medication if they have a known allergy to aspirin or any other pain reliever or fever reducer. It is essential to counsel patients to stop using the medication and consult a doctor if they experience any signs of stomach bleeding, which may include feeling faint, vomiting blood, having bloody or black stools, or experiencing stomach pain that does not improve. Additionally, patients should be made aware that they should seek medical advice if their pain worsens or lasts more than 10 days, if their fever worsens or lasts more than 3 days, or if they experience ringing in the ears or loss of hearing. They should also report any redness or swelling in the painful area or the appearance of any new symptoms.

Patients should be encouraged to consult a doctor before using the medication if they have a history of stomach problems, such as heartburn, or if the stomach bleeding warning applies to them. Furthermore, it is important to advise patients to seek medical advice before use if they have high blood pressure, heart disease, liver cirrhosis, or kidney disease. Patients taking a diuretic or those with asthma should also be advised to consult a doctor prior to use. Lastly, patients should be encouraged to speak with a doctor or pharmacist if they are taking a prescription drug for gout, diabetes, or arthritis.

Storage and Handling

The product is supplied in tamper-evident sealed packets to ensure integrity and safety. It is essential to store the packets at room temperature, avoiding exposure to excessive heat and humidity to maintain product efficacy. Healthcare professionals should not use any packets that are opened or torn, as this may compromise the product's quality and safety.

Additional Clinical Information

No further data are available.

Drug Information (PDF)

This file contains official product information for Crane Safety Aspirin, Thompson Aspirin, including active ingredients, dosage, warnings, and labeling as submitted by the manufacturer for OTC distribution.

View product document (PDF)